Unit-I National Accreditation Board for Testing and Calibration Laboratories (NABL), Pharmaceutical Quality Asurance

 

Introduction

Quality Council of India (QCI) is governed by a council of 38 members with equal representations of government, industry and consumers. Chairman of QCI is appointed by the Prime Minister’s office on recommendation of the government and industry. Council is the apex level body responsible for formulation the strategy, general policy, constitution and monitoring of various components of QCI with objective to ensure transparent and credible system.

Accreditation is the process in which certification of competency, authority, or credibility is presented.

Organizations that issue credentials or certify third parties against official standards are themselves formally accredited by accreditation bodies (such as UKAS or IAS); hence they are sometimes known as "accredited certification bodies". The accreditation process ensures that their certification practices are acceptable, typically meaning that they are competent to test and certify third parties, behave ethically and employ suitable quality assurance.

Why Accreditation?

Accreditation is the third party attestation related to a conformity assessment body conveying the formal demonstration of its competence to carry out specific conformity assessment task. Conformity Assessment Body (CAB) is a body which includes Testing including medical Laboratory, Calibration Laboratory, Proficiency Testing Provider, Certified Reference Material Producer.

(The laboratory accreditation services to testing and calibration laboratories are provided in accordance with ISO/ IEC 17025: 2005 & ISO/IEC 17025: 2017 ‘General Requirements for the Competence of Testing and Calibration Laboratories’ and ISO 15189: 2012 ‘Medical laboratories — Requirements for quality and competence’. The accreditation to Proficiency testing providers is based on ISO/IEC 17043: 2010 “Conformity assessment — General requirements for proficiency testing” and to reference material producers based on ISO 17034:2016 “General requirements for the competence of reference material producers”.)

The liberalization of trade and industry policies of the Government of India has created quality consciousness in domestic trade and provided greater thrust for export. As a consequence testing centers and laboratories have to demonstrably operate at an internationally acceptable level of competence.

Laboratory accreditation is a procedure by which an authoritative body gives formal recognition of technical competence for specific tests/ measurements, based on third party assessment and following international standards.

Similarly, Proficiency testing Provider accreditation gives formal recognition of competence for organizations that provide proficiency testing. Reference Material Producers Accreditation gives formal recognition of competence to carry out the production of reference materials based on third party assessment and following international standards.

NABL is a Constituent Board of Quality Council of India. NABL has been established with the objective of providing Government, Industry Associations and Industry in general with a scheme of Conformity Assessment Body’s accreditation which involves third-party assessment of the technical competence of testing including medical and calibration laboratories, proficiency testing providers and reference material producers.

In the current global scenario an essential pre -requisite of trade is that any product or service accepted formally in one economy must also be free to circulate in other economies without having to undergo extensive re-testing. WTO recognizes that non acceptance of test results and measurement data is a Technical Barrier to Trade. Global sourcing of components calls for equivalence of measurement, which can be facilitated by a chain of accredited CABs. Accreditation is considered as the first essential step for facilitating mutual acceptance of test results and measurement data.

(NABL went a step further in removing technical barriers to trade and achieved the status of signatory to Asia Pacific Laboratory Accreditation Cooperation (APAC) Mutual Recognition Arrangement (MRA) and International Laboratory Accreditation Cooperation (ILAC) Arrangement based on a peer evaluation by APAC in 2000. This was a major step towards mutual acceptance of test results and measurement data across Indian borders. NABL went through the peer APAC evaluation in 2004, 2008, 2012 & 2016 and reaffirmed its APAC / ILAC signatory status with extension of scope for Proficiency testing providers (PTP) as per the standard ISO/IEC 17043:2010 & Reference materials producers (RMP) as per the standard ISO 17034: 2016. Today, the test results and measurement data produced by Indian accredited CABs are acceptable amongst economies which MRA partners represent.)

NABL provides accreditation in all major fields of Science and Engineering such as Biological, Chemical, Electrical, Electronics, Mechanical, Fluid-Flow, Non-Destructive, Photometry, Radiological, Thermal & Forensics under testing facilities and Electro-Technical, Mechanical,

 

Fluid Flow, Thermal, Optical, Medical Devices & Radiological under Calibration facilities. NABL also provides accreditation for medical testing laboratories. In addition, NABL also offers accreditation for Proficiency testing providers & Reference Material producers and is now signatory to APAC MRA for both.

 

 

NABL Vision

To be the world’s leading accreditation body and to enhance stakeholders’ confidence in its services.

NABL Mission

To strengthen the accreditation system accepted across the globe by providing high quality, value driven services, fostering APAC/ILAC MRA, empaneling competent assessors, creating awareness among the stake holders, initiating new programs supporting accreditation activities and pursuing organizational excellence.

Benefits of Accreditation

Formal recognition of competence of a laboratory by an Accreditation body in accordance with international criteria has many advantages:

•      Increased confidence in Testing/ Calibration Reports issued by the laboratory  
•     Better control of laboratory operations and feedback to laboratories as to whether they have sound Quality Assurance System and are technically competent
•      Potential increase in business due to enhanced customer confidence and satisfaction.
•   Customers can search and identify the laboratories accredited by NABL for their specific requirements from the NABL Web-site or Directory of Accredited Laboratories
•    Users of accredited laboratories enjoy greater access for their products, in both domestic and international markets.
•       Savings in terms of time and money due to reduction or elimination of the need for re-testing of products.

Scope of Accreditation

NABL Accreditation is currently given in the following fields and disciplines. The multi-disciplinary CABs shall have to apply in relevant discipline separately depending upon to which discipline the scope belongs. For more details on scope of accreditation please refer the relevant specific criteria.

TESTING LABORATORIES	CALIBRATION LABORATORIES	MEDICAL LABORATORIES
· Biological · Chemical · Electrical · Electronics · Fluid-Flow · Mechanical · Non-Destructive Testing (NDT) · Photometry · Radiological · Forensic · Diagnostic Radiology QA Testing · Software & IT System	. Electro-Technical · Mechanical · Fluid Flow · Thermal . Optical . Radiological . Medical Devices	· Clinical Biochemistry · Clinical Pathology · Haematology & Immunohematology · Microbiology & Infectious Disease Serology · Histopathology · Cytopathology · Flow Cytometry · Genetics · Nuclear Medicine (in-vitro tests only)
MEDICAL IMAGING-CONFORMITY ASSESSMENT BODIES (MI-CAB) · Projectional Radiography & Fluoroscopy a. X-Ray, Bone Densitometry (DEXA), Dental X-Ray-OPG, Mammography etc. b. Fluoroscopy · Computed Tomography (CT) · Magnetic Resonance Imaging (MRI) · Ultrasound and Colour Doppler · Nuclear Medicine a. SPECT b. PET CT c. PET MRI · *Basic Diagnostic Interventional Radiology Procedures (Image guided Core Biopsy and/or Needle Aspiration eg. Fine Needle Aspiration Cytology) *for only such IR procedures that will be carried out by Radiologists.
PROFICIENCY TESTING PROVIDERS		REFERENCE MATERIAL PRODUCERS
· Testing · Calibration · Medical · Inspection		· Chemical Composition · Biological & Clinical Properties · Physical Properties · Engineering Properties · Miscellaneous Properties

Preparation & Eligibility for Accreditation

         1. Once the CAB decides to seek NABL accreditation, it should make a definite plan of action for obtaining accreditation and nominate a responsible person to co-ordinate all activities related to seeking accreditation who should be familiar with CAB’s existing quality system.

         2. The CAB should get fully acquainted with relevant NABL documents and understand the assessment procedure and methodology for filing an application.

        3. A CAB wishing to be accredited by NABL must have a System Document Quality Manual on its Quality System satisfying the requirements as described in various clauses of ISO/ IEC 17025:2017 or ISO 15189:2012 or ISO/IEC 17043:2010 or ISO 17034: 2016 whichever is relevant and requirements of relevant NABL specific criteria and needs to ascertain the status of its existing quality system and technical competence.

        4. The proposed person responsible for quality system or Quality manager shall have undergone 4-days formal training on management system and internal audit based on relevant standard.

         5. The CAB must ensure that the procedures described in the Quality Manual and other documents are being implemented. In case the laboratory performs site testing/ calibration, it must also comply with NABL 130 “Specific criteria for site testing and site calibration laboratories‟.

        6. The applicant CAB must have participated satisfactorily in the proficiency testing program, wherever applicable, conducted by NABL/ APLAC or any other national or international accredited/ recognised PT provider. If no suitable PT program is available the CAB can initiate an inter-laboratory comparison with adequate number of accredited laboratories. The minimum stipulated participation for laboratories is one parameter/ type of test/ calibration per discipline, prior to grant of accreditation and an on-going program as per NABL 163. The satisfactory performance shall be defined in term of z-score and En number respectively or any other acceptable internationally accepted method. For unsatisfactory performance, the CAB is to take corrective action and inform NABL. ISO/ IEC 17043, NABL 163 and NABL 164 give details of proficiency testing.

      7.  The applicant CAB must have conducted at least one internal audit and a management review before the submission of application.

Process of Accreditation

          1.The CAB is required to apply in the prescribed application form (NABL 151 for testing laboratories, NABL 152 for calibration laboratories, NABL 153 for medical laboratories, NABL 180 for PTP and NABL 190 for RMP), in three copies along with two copies of the quality manual of the CAB that should describe the management system in accordance with ISO/ IEC 17025: 2005 or ISO 15189: 2012 or ISO/IEC 17043:2010 or ISO 17034: 2016 whichever is applicable. The application is to be accompanied with the prescribed application fee as detailed in NABL 100. CAB has to take special care in filling the scope of accreditation for which the CAB wishes to apply. In case, the CAB finds any clause (in part or full) not applicable to the CAB, it is expected to furnish the reasons.

      2.NABL Secretariat on receipt of application form, the quality manual and the fees issues an acknowledgement to the CAB indicating a unique ID number, which is used for correspondence with the CAB. After scrutiny of application for its completeness in all respects, NABL Secretariat may ask for additional information/ clarification(s), if necessary.

         3. In case there are no inadequacies in the quality manual or after satisfactory corrective action by the CAB, a pre -assessment visit of the CAB is organised by lead assessor appointed by NABL. The pre-assessment of the CAB is conducted to evaluate non-conformities (if any) in the implementation of the quality system, to assess the degree of preparedness of the CAB for the assessment, to determine the number of assessors required in various fields based on the scope of accreditation, number of key location to be visited etc. The lead assessor submits a pre-assessment report to NABL Secretariat with a copy to the CAB. The CAB takes corrective actions on the non-conformities raised on the documented management system and its implementation and submits a report to NABL Secretariat.

       4.  After the CAB has taken satisfactory corrective actions, NABL finalizes the constitution of assessment team in consultation with the CAB. The team includes the lead assessor and technical assessor(s)/ expert(s) in order to cover various fields/ disciplines/ groups within the scope of accreditation sought. NABL may also nominate an observer. The assessment team reviews the CAB’s documented management system and verifies its compliance with the requirements of ISO/ IEC 17025: 2005 or ISO 15189: 2012 or ISO/IEC 17043:2010 or ISO 17034: 2016 whichever is applicable and relevant specific criteria and other NABL policies. The CAB’s technical competence to perform specific tasks is also evaluated. The non-conformities if identified are reported in the assessment report. It also provides a recommendation towards grant of accreditation or otherwise. The report prepared by the assessment team is sent to NABL Secretariat. However a copy of summary of assessment report and copies of non-conformities if any, are provided to the CAB at the end of the assessment visit.

      5.The assessment report is examined by NABL Secretariat and follow up action as required is initiated. CAB has to take necessary corrective action on non-conformities and submit a report to NABL Secretariat within 60 days. NABL monitors the progress of closing of non-conformities.  

         6.After satisfactory corrective action by the CAB, the Accreditation Committee examines the assessment report, additional information received from the CAB and the consequent verification, if any. In case everything is in order, the Accreditation Committee makes appropriate recommendations regarding accreditation of the CAB to the Chairman, NABL.

       7. All decision taken by NABL are open to appeal by the CAB. The appeal is to be addressed to the Director, NABL.

     8.When the recommendation results in the grant of accreditation, NABL issues an accreditation certificate which has an unique number and NABL hologram, discipline, date of validity along with the scope of accreditation.

     9.For site laboratory, tests/ calibrations performed at site are clearly identified in the scope of accreditation while issuing the certificate.

     10.  The applicant CAB must make all payments due to NABL, before the accreditation certificate(s) is/ are issued to them.

      11.  The accredited CABs at all times shall conform to the requirements of ISO/ IEC 17025: 2005 or ISO 15189: 2012 or ISO/IEC 17043:2010 or ISO 17034: 2016 whichever is applicable and relevant specific criteria and NABL Policies. The accredited CABs are required to comply at all times with the terms and conditions of NABL given in NABL 131 “Terms & Conditions for obtaining and maintaining NABL Accreditation‟.

      12.The NABL accreditation certificate is valid for a period of 2 years. NABL conducts annual Surveillance of the CAB at intervals of one year which is aimed at evaluating continued compliance to the requirements of ISO/ IEC 17025: 2005 or ISO 15189: 2012 or ISO/IEC 17043:2010 or ISO 17034: 2016 whichever is applicable and relevant specific criteria and NABL Policies.

       13.  The accredited CAB is subjected to re-assessment every 2 years. The CAB has to apply 6 months before the expiry of accreditation to allow NABL to organise assessment of the CAB, so that the continuity of the accreditation status is maintained